Immuno-Oncology Drugs GLS-012 Alone & in Combination GLS-010 Treating With Advanced Patients Solid Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Solid Tumor

In brief

This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.

Key facts

Study ID

NCT05909436

Run by

Guangzhou Gloria Biosciences Co., Ltd.

People needed

107

Starts

2022-10-31

Expected to finish

2026-12-01

Last updated by the study team

2023-06-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who are willing to sign the informed consent form;
• Aged 18-75 years, male or female;
• Histologically confirmed diagnosis of a solid tumor;
• Patients with advanced solid tumors after progression on standard treatment;
• Subjects must have at least 1 measurable target lesion according to RECIST version 1.1；
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1；
• Life expectancy more than 12 weeks;
• Adequate organ function and bone marrow function as indicated by the screening assessments in the screening period;
• Women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment.

You may not qualify if…

• Patients with irAEs of grade ≥ 3 in the previous immunotherapy, and the AEs of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and AEs with no safety risks judged by the investigators, for example, alopecia.
• Patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization.
• Use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration;
• Known central nervous system (CNS) metastases;
• Patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past.
• Patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma.
• Cardiac clinical symptoms or diseases that are not well controlled.
• Known hereditary or acquired bleeding and thrombosis tendency.
• Patients with congenital or acquired immunodeficiency disorders (such as HIV-infection), or a history of organ transplantation.
• Patients complying with any of hepatitis B surface antigen (HBsAg) positive and HBV-DNA copies being more than 2500 copies/ml (or 500 IU/ml); or positive HCV-RNA;
• Patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.

Where it is running

• Beijing Cancer Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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